0354 21cfr123

§ 123.7

21 CFR Ch. I (4–1–06 Edition)

that food safety hazard. A HACCP plan
for such fish and fishery products shall
address any other food safety hazards
that are reasonably likely to occur.
(f) Sanitation. Sanitation controls
may be included in the HACCP plan.
However, to the extent that they are
monitored in accordance with § 123.11(b)
they need not be included in the
HACCP plan, and vice versa.
(g) Legal basis. Failure of a processor
to have and implement a HACCP plan
that complies with this section whenever a HACCP plan is necessary, otherwise operate in accordance with the requirements of this part, shall render
the fish or fishery products of that
processor adulterated under section
402(a)(4) of the act. Whether a processor’s actions are consistent with ensuring the safety of food will be determined through an evaluation of the
processors overall implementation of
its HACCP plan, if one is required.
§ 123.7 Corrective actions.
(a) Whenever a deviation from a critical limit occurs, a processor shall take
corrective action either by:
(1) Following a corrective action plan
that is appropriate for the particular
deviation, or
(2) Following the procedures in paragraph (c) of this section.
(b) Processors may develop written
corrective action plans, which become
part of their HACCP plans in accordance with § 123.6(c)(5), by which they
predetermine the corrective actions
that they will take whenever there is a
deviation from a critical limit. A corrective action plan that is appropriate
for a particular deviation is one that
describes the steps to be taken and assigns responsibility for taking those
steps, to ensure that:
(1) No product enters commerce that
is either injurious to health or is otherwise adulterated as a result of the deviation; and
(2) The cause of the deviation is corrected.
(c) When a deviation from a critical
limit occurs and the processor does not
have a corrective action plan that is
appropriate for that deviation, the
processor shall:
(1) Segregate and hold the affected
product, at least until the require-

ments of paragraphs (c)(2) and (c)(3) of
this section are met;
(2) Perform or obtain a review to determine the acceptability of the affected product for distribution. The review shall be performed by an individual or individuals who have adequate training or experience to perform
such a review. Adequate training may
or may not include training in accordance with § 123.10;
(3) Take corrective action, when necessary, with respect to the affected
product to ensure that no product enters commerce that is either injurious
to health or is otherwise adulterated as
a result of the deviation;
(4) Take corrective action, when necessary, to correct the cause of the deviation;
(5) Perform or obtain timely reassessment by an individual or individuals
who have been trained in accordance
with § 123.10, to determine whether the
HACCP plan needs to be modified to reduce the risk of recurrence of the deviation, and modify the HACCP plan as
necessary.
(d) All corrective actions taken in accordance with this section shall be
fully documented in records that are
subject to verification in accordance
with § 123.8(a)(3)(ii) and the recordkeeping requirements of § 123.9.
§ 123.8 Verification.
(a) Overall verification. Every processor shall verify that the HACCP plan
is adequate to control food safety hazards that are reasonably likely to
occur, and that the plan is being effectively implemented. Verification shall
include, at a minimum:
(1) Reassessment of the HACCP plan. A
reassessment of the adequacy of the
HACCP plan whenever any changes
occur that could affect the hazard analysis or alter the HACCP plan in any
way or at least annually. Such changes
may include changes in the following:
Raw materials or source of raw materials, product formulation, processing
methods or systems, finished product
distribution systems, or the intended
use or consumers of the finished product. The reassessment shall be performed by an individual or individuals
who have been trained in accordance
with § 123.10. The HACCP plan shall be

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